Kornimate/medical-research-clean huggingface dataset:
mascot registry of patients with myeloproliferative neoplasms associated splanchnic vein thrombosis

Conditions: Myeloproliferative Neoplasm; Splanchnic Vein Thrombosis; JAK2 V617

Summary: a registry of uk patients diagnosed to have splanchnic vein thrombosis and myeloproliferative neoplasm, including isolated mutation of jak2v617f. the purpose of the registry is to understand outcomes, treatment variations and data to inform and enable future clinical trial design and facilitate regulatory approval decision-making.

splanchnic or abdominal vein thrombosis (svt) comprises thrombosis of hepatic, portal, superior mesenteric, splenic vein in isolation or combination. it has a prevalence of 1-2% in the general population based on autopsy reports. however, 40-50% of patients with hepatic vein thrombosis and about 25-30% of patients with pvt have an underlying myeloproliferative disease that is the cause of the thrombosis. although some data on mpn-svt have been published from european registries, the lack of sufficient clinical and scientific data in these patients has led to variation in treatment patterns with regard to timing, choice and duration of anticoagulation, the use of cytotoxic or biologic agents and interventions with thrombolysis and stenting with tipss in the acute stage. data on the patterns of treatment of these patients in u.k and their outcomes with regard to morbidity and mortality are lacking. availability of such data in u.k. will lead to the design of good quality prospective interventional studies. project design this registry is designed for longitudinal real-world data collection on uk patients with mpn-svt who are managed at tertiary liver centres in u.k. a pre-defined data set, built by a committee of specialist clinicians from the mascot registry investigators will be collected and entered into the electronic web-based database built by dendrite clinical systems ltd. the data captured includes demographic information linked to the nhs number, which will enable linked-anonymous data accrual and analysis as well as correlation with the systemic anti-cancer therapy data set (sact) via the national cancer registration and analysis service (ncras) and cancer drug fund (cdf) database. it will also allow interrogation of the national registries for stroke (ssnap) and cardiac surgery (nacsa) as co-morbidities involving arterial circulation are prevalent in 30% of patients.

Eligibility criteria:
inclusion criteria: * age\>18 years * myeloproliferative neoplasm (mpn, who 2008, who 2016, bcsh) and splanchnic vein thrombosis * isolated jak2v617f allele and splanchnic vein thrombosis * mpn and portal cavernoma exclusion criteria: -

Keywords: registry
pelvic floor repair systems for prolapse repair

Conditions: Pelvic Organ Prolapse

Summary: 1. this is a prospective, multi-center, post market study, which will be conducted under a common protocol. 2. the primary objective of the study is to evaluate long-term efficacy of the ams pelvic floor repair system devices for prolapse repair. 3. the study population is female subjects \> 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse. 4. the clinical data will be analyzed by comparing post-treatment data with the baseline data, with the subject acting as her own control. the follow-up is for two years after the procedure. 5. prolapse improvement measured by ics pop-q stage at 12-months will be the primary endpoint of the study. the secondary endpoints include quality of life changes from baseline and adverse event rates.


Eligibility criteria:
inclusion criteria: -have been diagnosed with one or more clinically significant anterior, apical or posterior genital prolapse disorder(s) (symptomatic pop-q stage ii or higher) requiring surgical repair exclusion criteria: * the investigator determines the subject is not a candidate for surgical repair of her genital prolapse. * subject has had a prior prolapse implant/procedure (i.e., ivs tunneler, perigee, apogee, graft augmented repair, etc) note: previous traditional repairs are allowed. * subject has active or latent systemic infection or signs of tissue necrosis. * subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement/prosthesis. * subject is currently pregnant or intends to become pregnant during the study period. note: the risks and benefits of performing the procedure if the subject is planning future pregnancies should be carefully considered. * subject has had radiation therapy to the pelvic area. * subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months. * subject has a known hypersensitivity to the graft material(s). * subject has uncontrolled diabetes. * subject is on any medication which could result in compromised immune response, such as immune modulators. * subject was involved in any other research trial \< 30 days of enrollment into this study. * subject has undergone previous pelvic surgery \< 6 months prior to enrollment in this study. * subject is unwilling or unable to give valid informed consent. * subject is unwilling or unable to comply with the requirements of the protocol, complete all quality of life questionnaires and return for all follow-up visits. * subject is contraindicated based on intended use and warnings in the ams pfr system devices for prolapse repair instructions for use (ifu).

Keywords: pelvic floor repair prolapse mesh
nebulized beclomethasone dipropionate improves respiratory lung function in preschool children with recurrent wheezing

Conditions: Wheezing

Summary: this is a single-centre, open label study, aiming to evaluate the efficacy of beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg nebulized), on airway resistance and reactances (measured with rint and fot techniques) in children with recurrent wheezing, aged 2-5 years. in addition, clinic score as frequency of symptoms and exacerbations, will be assessed.


Eligibility criteria:
inclusion criteria: * informed and subscribed consent before any procedure * age range : 2 - ≤5 years * male and female patients * recurrent wheezing affected ( ≥ 4 episodes in the last 12 months) * pai positive (at least one primary and two secondary ): primary: 1. one parent with asthma 2. atopic dermatitis 3. sensibilisation to air allergen secondary: 1. food sensibilization 2. wheezing also not during the infective episodes 3. eosinophilia (\>4%) exclusion criteria: * story of severe wheeze requiring hospitalization * treatment with inhaled glucocorticoids during the previous 4 weeks or with oral glucocorticoids in the previous 8 weeks * structural abnormalities of the lungs (tracheobronchial bronchomalacia, external compressions, etc) * persistent infections * aspiration lung disease (gastroesophageal reflux disease, etc.) * cystic fibrosis * prematurity or bronchopulmonary dysplasia * tuberculosis * primary ciliary dyskinesia * congenital heart disease * pulmonary foreign body * bronchiectasis * immunodeficit

Keywords: wheezing children
observational longitudinal study of pain in men with metastatic castrate-resistant prostate cancer

Conditions: Metastatic Castrate-Resistant Prostate Cancer

Summary: this is a single-arm observational longitudinal study in of patients with metastatic castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain and other symptoms.

this is a single-arm observational longitudinal study in of patients with metastatic castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain and other symptoms. the study aims to address several key methodological questions that will inform the design of future clinical trials with symptom endpoints in this population, including: the definition of "clinically meaningful" pain; criteria for concluding a clinically meaningful pain reduction; criteria for concluding clinically meaningful pain progression; reliable methods quantifying analgesic use (given that "equianalgesic tables" and "point scoring systems" are generally considered unreliable by pain researchers and regulatory agencies , , ); ideal recall periods for pain questions; tradeoffs of different frequencies of symptom reporting; symptom trajectories over time; and associations of pain scores with other metrics used in prostate cancer research (imaging, psa values, circulating tumor cells, etc).

Eligibility criteria:
inclusion criteria: * the subject must be ≥ 18 years old on the day of consent. * the subject is able to understand written and spoken english * the patient must have histologically or cytologically confirmed prostate adenocarcinoma. * the subject must have castration-resistant prostate cancer (crpc) * the subject must have metastatic disease involving bone, seen on radiographic imaging (bone scan, ct scan, pet scan, or mri). * the subject must be in a castrate state (e.g., currently receiving androgen deprivation therapy or have had an orchiectomy). * the subject must be starting any line treatment post-androgen deprivation/antiandrogen therapy, such as the following: chemotherapy (e.g., docetaxel, paclitaxel, carboplatin, cabazitaxel, or mitoxantrone); abiraterone acetate; mdv3100; ketoconazole; sipuleucel-t; radium 223. * the subject owns or has regular access to a telephone (cellular or land line). * the subject is willing and able to self-report pain and analgesic use via an automated telephone system. * the subject is willing and able to provide informed consent. exclusion criteria: * the subject has small cell or predominantly neuroendocrine differentiated prostate tumor.

Keywords: metastatic castrate-resistant prostate cancer lccc 1231 lineberger comprehensive cancer center unc lineberger prostate cancer pain
continuous glucose monitorization in hospitalized patients with covid-19

Conditions: Diabetes Mellitus; Covid19

Summary: dm2 is a major comorbidity of covid-19. it has been observed that subjects with dm2 require more medical interventions, have a significantly higher mortality (7.8% versus 2.7%) and injuries of multiple organs that the individuals not diabetics. in situations of glycemic variability, phenomena of oxidative stress and activation of protein kinase c can be initiated , through the release of pro-inflammatory cytosines , which could induce microvascular damage .patients with diabetes and covid-19 were shown to be more likely to develop serious or critical illness with more complications, and to have higher incidence rates of antibiotic therapy, non-invasive and invasive mechanical ventilation, and death (11.1% vs. 4.1%).


Eligibility criteria:
inclusion criteria: * confirmed covid-19 pneumonia * diabetes mellitus exclusion criteria: * less than 3 days of hospital care
the benefits of vitamin d 5000 iu as add on therapy in the management of painful diabetic neuropathy patient

Conditions: Painful Diabetic Neuropathy

Summary: diabetic neuropathy is one of the micro-vascular complications of diabetes, 30-50% occurring in all diabetic patients. this complication is one of the major cause of morbidity and mortality in diabetic patientsand leading to a deterioration of their quality life. a deficiency of vitamin d \[25-hydroxyvitamin d, 25(oh) d\] is common in patient with diabetes and low concentrations are associated with the presence and severity of sensory neuropathy in diabetes. vitamin d deficiency has been shown to be an independent risk factor for diabetic peripheral neuropathy (dpn). topical and oral vitamin d have been reported significantly reduce the symptoms and the pain of dpn. however, no case control clinical trial have been reported that demonstrate the efficacy of vitamin d supplementation on the symptoms of dpn. painful in diabetic neuropathy is a major complication of diabetes, characterized by pain, tingling, burning and cramps in the lower legs and feet with a signification reduction in quality of life. recently, there shown a significant reduction in the severity of painful diabetic neuropathy after treatment with vitamin d. patient with diabetes have a poor quality of life compared to person without diabetes. the current study assessed the benefits of add on oral vitamin d 5000 iu on diabetic neuropathy patient to pain impact in daily life.

this was randomized clinical trial, active comparator, open label, controlled study from the period of november 2020 - november 2021 at bethesda hospital, yogyakarta, indonesia. there were 60 painful diabetic neuropathy patients who fulfilled the inclusion and exclusion criteria. each subject had been followed up from the first day of medication administration until 8 weeks after medication administration. ethical approval number ((kosong)) was obtained from health research ethics committee, bethesda hospital yogyakarta. the hypothesis of this study: a. add on oral vitamin d 5000 iu to standard treatment in patients with painful diabetic neuropathy is more effective in reducing pain and neuropathic symptoms in 8 weeks of treatment compared with standard treatment, b. add on oral vitamin d 5000 iu to standard treatment in patients with painful diabetic neuropathy is as safe as standard treatment.

Eligibility criteria:
inclusion criteria: * male or female * adult age (\>18 years old) * diagnosed as painful diabetic neuropathy based on validated diabetic neuropathy symptoms (dns) and diabetic neuropathy examination (dne) * low vitamin d status of \<30 ng/ml exclusion criteria: * subjects with significant renal and liver problem * subjects with known hypersensitivity to vitamin d 5000 iu * pregnancy and breastfeeding patients * patients that enrolled any clinical trial within a month * not competent enough in giving approval and answering questionnaires

Keywords: vitamin d standard therapy neuropathy diabetic neuropathy
accolade® tmzf® hip stem outcomes study

Conditions: Arthroplasty, Replacement, Hip

Summary: the purpose of this study is to evaluate clinical and radiographic outcome data in patients implanted with the accolade® tmzf® femoral stem.

a prospective, post-market, multi-centered clinical evaluation of the accolade® tmzf® hip stem device. all patients enrolled will receive the study device. all study patients will undergo a preoperative central dual energy x-ray absorptiometry (dxa) scan to determine bone mineral density (bmd) values.

Eligibility criteria:
inclusion criteria: 1. patient is a candidate for a primary total hip replacement. 2. patient has primary diagnosis of osteoarthritis (oa). 3. male and non-pregnant female patients ages 18 to 90. 4. patient has signed an institutional review board (irb) approved, study specific informed patient consent form. 5. patient willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation. 6. patient capable of undergoing a pre-op central dxa (dual-energy x-ray absorptiometry) scan for a bone mineral density (bmd) reading. exclusion criteria: 1. patient has an active infection within the affected hip joint. 2. patient requires a revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint. 3. patient who is morbidly obese, body mass index (bmi) \> 40. 4. patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device. 5. patient has the following diagnosed systemic diseases: paget's disease, renal osteodystrophy, lupus erythematosus, rheumatoid arthritis, metabolic bone disease and sickle cell anemia. 6. patient is immunologically suppressed or receiving chronic steroids more than 30 days. patients receiving oral or iv steroids within one month of surgery. 7. patient is a prisoner.

Keywords: osteoarthritis
evaluation of renal function in patients with hyperthyroidism

Conditions: Hyperthyroidism

Summary: to evaluate the effect of subclinical and overt hyperthyroidism in renal function

* thyroid disorders are very common with a high prevalence among the general population. thyroid diseases are associated with many detrimental effects that have a serious impact on various body systems.(1) * hyperthyroidism can be overt or subclinical. overt hyperthyroidism is defined as low serum thyroid stimulating hormone (tsh) and elevated serum thyroxin (t4), tri-iodothyronine (t3), or both. whereas subclinical hyperthyroidism (sch) is defined as low serum tsh level with normal serum levels of t3 and t4.(2) * the relationship between thyroid hormones and kidney function is well-known for many years. thyroid diseases adversely affect renal physiology; meanwhile, kidney diseases could result in thyroid dysfunction. * thyroid hormones contribute to the maintenance of water and electrolyte balance, and participate in the renal transport system. hyperthyroidism results in an increased glomerular filtration rate (gfr) by about 18-25%. due to increased renal blood flow and activation of renin angiotensin-aldosterone system (raas). also, these changes have been reported in patients with hyperthyroidism.(3-5) * several mechanisms were found playing roles on increasing both the size and functional capacity of kidney: 1. thyroid hormone directly influences the expression and activity of most of renal transporters by direct binding of thyroid hormone to the promoter region of a transporter gene (6) 2. in hyperthyroid state beta-adrenergic receptors in kidney cortex, and synthesis and secretion of renin by juxtaglomerular cells are increased, which in turn enhance angiotensin-converting enzyme activity.(7) 3. increased raas activity results in afferent arteriolar vasodilatation and efferent arteriolar vasoconstriction with a consequent increase in the filtration pressure...(8) d) hyperthyroidism increases systolic blood pressure by increasing heart rate, decreasing systemic vascular resistance, raising cardiac output, and increases nitric oxide production which all contributes to the hyper dynamic circulation. hyperthyroidism results in increased renal blood flow.(7) * observed that both bun and creatinine levels increased significantly after euthyroidism was achieved in hyperthyroid patients, these findings point out to true decline in renal function rather than a mere adaptation to hemodynamic changes. although the mechanistic link between thyroid and kidney disease remains unclear, hyperthyroidism may have significant effect on renal function

Eligibility criteria:
inclusion criteria: * patients aged (18_80 years) diagnosed subclinical and overt hyperthyroidism with overt hyperthyroidism exclusion criteria: 1. patients with d.m 2. patients with hypertension 3. patients with ckd or esrd 4. ihd 5. pateints receiving medication known to affect renal function as contrast agent, non-steroidal anti-inflammatory drugs and aceis
enhancing self regulation as a strategy for obesity prevention in head start preschoolers

Conditions: Obesity

Summary: the goal of this integrated project targeting the childhood obesity prevention challenge area is to reduce the prevalence of obesity among children attending head start in michigan. the proposed intervention program is based on social cognitive theory and the premise that enhancing children's capacity for emotional and behavioral self-regulation is a key component of effective obesity prevention. a randomized controlled trial design is proposed to evaluate, among 600 head start children and their parents, the effectiveness of 2 approaches to obesity prevention: (1) the parents of preschoolers prevention series (pops), a curriculum delivered to preschoolers and their parents focused on obesity-related health behaviors; and (2) pops in combination with the incredible years series (iys), an evidence-based program designed to improve preschoolers' emotional and behavioral self-regulation. the research objective is to test the hypotheses that: (1) pops, compared to usual head start exposure, will lead to greater improvements in obesity-related health behaviors and adiposity indices; and (2) pops + iys will lead to the greatest improvements in obesity-related health behaviors and adiposity indices, and this effect will be mediated by improved self-regulation. the extension objective is to evaluate the feasibility, fidelity, and educational effectiveness of the pops and pops + iys interventions, as delivered by paraprofessionals and educators within extension and head start. the education objective is to provide extension and head start staff non-formal training and educational curricula which can be widely disseminated. the long-term goal of this project is disseminate a novel and effective approach to obesity prevention in preschoolers.


Eligibility criteria:
inclusion criteria: * child is enrolled in head start exclusion criteria: * significant developmental disabilities that would preclude participation * child is a foster child * parent is non-english speaking

Keywords: obesity prevention children
does the format of the adult adhd self-report scale impact the results

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the world health organization adult adhd self-report scale v1.1 (asrs) is frequently used in family medicine clinics to screen for adhd. numerous studies have found the asrs has a low positive predictive value. compounding this concern is the format of the asrs. specifically, the answers on the asrs that lead to screen positive results are shaded in gray and grouped together, which may make it easy for patients to discern which responses should be selected for a positive screen.

the asrs is used widely to screen for adhd in adults. it has 18 questions, with response options "never," "rarely," "sometimes," "often," and "very often." the 6 questions considered most predictive of adhd are grouped together in part a and questions that are meant to provide additional cues are grouped together in part b. the options that are considered a positive response vary between questions; for some questions the option is at least "sometimes," while for others it is at least "often." the positive response options are shaded on the asrs. a person is considered to have a positive screen if 4 of the 6 questions in part a are positive. the objective of this trial is to determine if the shading and grouping on the asrs impacts screening results. this trial has a 2x2 factorial design set in a family medicine clinic(s). when a patients check in for an appointment, clinic staff will offer them a survey that includes 1) demographic questions and 2) 1 of the 4 versions of the asrs, the version they receive is randomized (with programming). most patients will take approximately 5 minutes to complete the survey prior to them seeing the family physician.

Eligibility criteria:
inclusion criteria: * 19 - 65 years old * patients who are registering for their appointment at the family medicine clinic * patients who are expected to be in the reception area for ≥5 minutes before going to a clinic room exclusion criteria: * any patients who do not have the capacity to complete the form (e.g., cognitive impairment, unable to read english, unable to use a computer)